- Processes local IRB submissions to include new research projects, amendments, adverse events and study terminations.

- Processes FDA submissions Establish and maintain research project's regulatory files.\

- Ongoing communication with the local IRB, federal organizations, affiliate institutions and pharmaceutical study sponsors.

- Ongoing communication within the research team regarding research project changes.

- Collects, records and maintains accurate data reporting adhering to protocol data collection protocol and federal guidelines.

- Clarifies Data Queries.

- Coordinates with the Clinical Research RN to organize procurement of research samples and then prepares, packages and ships research samples.

- Manages research sample supplies.

- Participates in Cooperative Group Audits, NCI, FDA, Sponsor GCP quality audits, Loyola internal audits and department audits.

- Performs related duties as assigned.

Minimum Education:

Required: Bachelors Degree OR equivalent training acquired via work experience or education

Preferred: Bachelors Degree

Specify Degree(s): Bachelor of Science

Minimum Experience:

Required: Less than one year of previous job-related experience

Preferred: 1-2 years of previous job-related experience

Details: Clinical trials experience

- Ability to follow oral and written instructions and established procedures.

- Ability to perform basic filing, office procedures and word processing.

- Ability to maintain accuracy and consistency.

- Ability to communicate verbally.

- Ability to finish tasks in a timely manner.

- Ability to maintain confidentiality.

- Ability to compose letters and memorandums.

- Ability to deal calmly and courteously with people.

- Ability to analyze and interpret data.

- Ability to function independently and manage own time and work tasks.

- Ability to work as an effective team member.

- Ability to organize workflow.

- Ability to negotiate, persuade and establish direction.

- Ability to maintain office files and follow standard office procedures.

- Skilled job requiring high level of adaptability & interpersonal skills.

- Ability to interact with internal and external constituents. Preferred experience in Hematology and Bone Marrow Transplant

CCRA (Certified Clinical Research Associate) or equivalent (SoCRA or ACRP) preferred

- Proficiency with Microsoft Word, Groupwise, EPIC, Microsoft Excel, Basic Keyboarding Skills, Adobe Acrobat, Beacon.

- Clinical Trials Management System.

- Electronic data entry web based data bases.